Miniature ingestible capsule

ABSTRACT

A miniature ingestible capsule has multiple therapeutic or diagnostic operations that can be performed. These functions are controlled by a combination of an outside control, a pose beacon and through information relayed from an imagining array and transmitter. These functions can be in a separate capsule without an imaging array or within the same capsule with an imaging array. Typically, there is one function performed in addition to imaging. These functions can include suction and spray capabilities, ultrasound sensor, lithotripsy, laser, heat, electrocautery, BICAP, biopsy forceps, a needle knife snare cautery (cold and hot with continuous or pulsed current for cutting and coagulation), with a basket, and fine needle aspiration with various wheels and fins and motors controlled externally and other tools to be used in humans. All of these tools can be attached to a retractable arm. Also, they can be used on an elevator device that lifts them, allowing for an extra 180° of movement.

[0001] This application claims priority from U.S. ProvisionalApplication Serial No. 60/180,960, filed on Feb. 8, 2000.

FIELD OF THE INVENTION

[0002] This invention relates to a miniature ingestible capsule forimaging the gastrointestinal tract for medical diagnosis or diagnosisand/or therapy for the human body. More specifically, this inventionrelates to noninvasive, noninterventional methods for internalexamination of the gastrointestinal tract or other internal therapy anddiagnosis of the human body that are significantly more convenient,comfortable, lower in cost and more advanced compared with currentinvasive diagnostic methods such as colonoscopy, sigmoidoscopy,esophagogastroduodenoscopy and push enteroscopy.

BACKGROUND OF THE INVENTION

[0003] The mammalian gastrointestinal tract comprises the esophagus,stomach, small intestine, and colon. Physicians image the interior ofthe gastrointestinal tract to aid in the diagnosis and treatment of manyillnesses such as ulcers, growths, cancers and bleeding spots. Morespecifically, these conditions include colorectal cancer, colonicpolyposis, inflammatory bowel disease, irritable bowel syndrome,Barrett's esophagus, peptic ulcer disease and dyspepsia.

[0004] Colorectal cancer, for example, is the second leading cause ofcancer death in the United States, with 133,500 new cases detected in1996, 54,900 (41%) of which resulted in death. (Agency for Health CarePolicy & Research (AHCPR) Research Activities 200:15-16, 1997.) Survivalrates improve and treatment costs decline with early detection of theprocess. (Brown, M. L. and Fintov, L. The economic burden of cancer. InGreenwald, P. Kramer, B. S., and Weed, D. L., eds Cancer Prevention andControl. New York, Marcel Decker, pp. 69-81, 1995. Healthy People 2000:Nutritional Health Promotion and Disease Prevention Objectives. U.S.Department of Health and Human Services, Public Health Service, DHHSPublication No. (PHS) 91-50212, p. 423, 1991.) However, regularscreening for colorectal cancer is not performed for the vast majorityof the populace due to the high cost of such programs and, moreimportantly, the reluctance of a healthy population at risk to undergoan invasive procedure again and again for surveillance against cancer.As a result, over two-thirds of patients are diagnosed with advanceddisease. (Eddy, D. M. Screening of colorectal cancer Ann. Int. Med.113:373, 1990).

[0005] The only low-cost noninvasive screening tests for colorectalcancer are fecal occult blood tests, which look for the presence offecal occult blood in stool specimens. These tests exhibit poorsensitivity due to the fact that malignant growths of the colon have tobe fairly large before they start to bleed. Furthermore, there are manyother reasons for bleeding into the gastrointestinal tract (e.g.,ulcers) which lead to low specificity of the test and a high probabilityof false positives. (Eisner, M. S., and Lewis, J. A. Diagnostic yield ofpositive FOBT found on digital rectal examination. Arch. Int. Med.151:3180, 1991. Rockey, D. C., Koch, J., Cello, J. P., Sanders, L. L.,McQuaid, K. Relative Frequency of Upper Gastrointestinal and ColonicLesions in Patients with Positive Fecal Occult-Blood Tests.) Even withthe poor characteristics of fecal occult blood tests, the AmericanCancer Society estimated that the regular use of the test in men overage 50 could produce a 15% reduction in mortality. (Agency for HealthCare Policy & Research (AHCPR) Research Activities 200:15-16, 1997.)

[0006] The most common diagnostic procedure for colonic examination iscolonoscopy. This procedure involves the optical examination of theentire colon using a device known as a colonoscope. A colonoscopecomprises a flexible tube containing a fiber optic imaging andilluminating device and a device to resect portions of the surface ofthe intestinal tract. The colonoscope is inserted into the rectum andcan be maneuvered to the ileo-cecal junction (the start of the colon).The operator views the image on a video display. The medical teamperforming this procedure usually comprises a gastroenterologist,specially trained nurses and at times an anesthesiologist. Polyps(tumors) are identified visually and biopsied. If examination of thespecimen reveals malignancy, a surgical team resects the regionscontaining the tumors. Usually, this is followed by a period ofchemotherapy, administered to fight unobserved or secondary tumors;annual colonoscopies may be prescribed. Considering the cost of thecolonoscopy alone, a yearly colonoscopy for all patients over age 48 forinstance, would be prohibitively expensive. Colonoscopy for asymptomaticpatients is seldom prescribed.

[0007] The sigmoidoscope is similar to a colonoscope, but can only beused to image the lower ⅔ of the colon. Although simpler than acolonoscope, its operation still requires the presence of a highlytrained physician and often requires sedation.

[0008] The esophagogastroduodenoscope is used to image the uppergastrointestinal tract, namely, the esophagus, the stomach and theduodenum. It is inserted through the mouth. Again, its operationrequires the presence of a highly trained physician and often requiressedation.

[0009] The esophagogastroduodenoscope is used to identify ulcers,gastritis, AVMs, esophagitis, varices, duodenitis, Barrett's esophagus,hiatal hernias and tumors. The esophagogastroduodenoscope procedure isperformed on patients with a variety of symptoms that include nausea,vomiting, abdominal bloating, abdominal pain, heartburn, reflux, familyhistory of cancer, jaundice, weight loss, anemia, and gastrointestinalbleeding. A majority of those procedures are diagnostic. considering thecost of endoscopy and the sedation requirement, it would beprohibitively expensive to perform esophagogastroduodenoscopy on allpatients with symptoms.

[0010] The push enteroscope is used to image the third and fourthportions of the duodenum and the proximal jejunum. It is insertedthrough the mouth. Its operation requires the presence of a highlytrained physician and requires sedation. The push enteroscope may beused to detect arteriovenous malformations and small intestinal tumors.

[0011] The endoscopic retrograde cholangiopancreatograph procedure isdone to visualize, to treat, and to diagnose pancreatic and biliarydiseases. The endoscopic ultrasound and transesophageal ultrasound areused to image the esophagus, adjacent mediastinal structures, lungs,pancreas, aorta and other vessels, colon and heart. These techniquesallow for tissue aspiration through a fine needle. Each of theseprocedures involve the passage of and endoscope through the mouth. Theiroperation requires the presence of a highly trained physician and a lotof sedation.

[0012] The present invention is a type of non-tethered device that isingested by the patient, thereby passing through the entiregastrointestinal tract, sending images and data through a telemetrymeans. There are several prior systems that use an ingestible device toprovide data on the internal state of a patient. The Heidelberg capsulerelays pH information through a radio frequency (RF) link, and canrelease medicament on a signal from an external transmitter. TheKonigsberg capsule monitors temperature and uses a RF link. The Cortemppill, which is commercially available at this time, also monitors thebody temperature, but uses a near-field magnetic link.

[0013] More sophisticated approaches such as colonoscopy and relatedgastrointestinal imaging methods, namely, sigmoidoscopy andesophagogastroduodenoscopy, are more effective because they can identifyabnormalities before the occurrence of late-stage symptoms (e.g., bloodin the stools for colonic tumors or tarry stools for peptic ulcers).However, these methods see limited use for several reasons. One, theyare invasive and uncomfortable to the patient, requiring sedation sothat a flexible fiberoptic tube can be inserted into the tract. This isa major limitation of these tests in their application to healthyasymptomatic individuals for repeated examinations (every 1-3 years).

[0014] Secondly, these tests are expensive, requiring the presence of aphysician and other personnel. Third, they are inconvenient, requiringthe patient to take a purgative, fast overnight, and remainincapacitated during the procedure.

[0015] Thus, there is a medical and economic benefit for an inexpensive,noninvasive, miniature, ingestible imaging or diagnostic device thatallows the patient to use the device while still performing the normalactivities of daily living. Furthermore, it would eliminate the need forhighly trained personnel for its operation. In light of the high cost ofcurrent imaging methods (and their subsequent limited and late-stageapplication), hospitals, clinical laboratories, and Health ManagementOrganizations (HMOs), will be able to employ these devices as acost-containment strategy.

[0016] Accordingly, it has been considered desirable to develop a newand improved miniature diagnostic and therapy device which wouldovercome the foregoing difficulties and others and meet the above-statedneeds while providing better and more advantageous overall results.

BRIEF SUMMARY OF THE INVENTION

[0017] The present invention relates to a miniature capsule. Moreparticularly, it relates to a miniature non-digestible capsule,ingestible by a human or other animal for performing internal diagnosticor therapeutic functions.

[0018] One embodiment of the capsule comprises an impermeable anteriorand posterior membrane, a transparent window, an imaging device, a posebeacon, a transmitter, and a power supply, and an external unitcomprising a data reception device, a recording device, and a posedetection system. Ingested by a patient, the capsule will pass throughthe entire gastrointestinal tract of the patient, providing real-timecircumferential images of the esophagus, stomach, small intestine, andcolon, which can be viewed and recorded by the physician. The capsuleexits the patient through the rectum. The device can either be discardedor reused by replacing the membranes.

[0019] A miniature color imaging device, such as a CCD array and lens,and an illumination device, such as an RGB diode array or similarlow-power white light source provide real-time color images of thegastrointestinal tract. The image is transmitted in real-time by atransmitter, such as a miniaturized UHF video transmitter, to anexternal reception device, such as a television monitor and a recordingdevice, such as a video cassette recorder. The capsule may be weightedin such a way as to maintain a particular orientation in the stomach. Insimultaneous operation with the imaging system is a sixdegree-of-freedom pose detection device that calculates the real-timepose of the capsule, thus tracking the device through patient's bodyrelative to a fixed external reference frame that may be strapped to thepatient's abdomen.

[0020] In one arrangement, this device is a passive beacon which istracked by an external detector strapped to the patient's body, whichrelays pose data that is correlated with received video data by acomputer. Alternatively, the pose detector may be an active device whosedata is either multiplexed with the image data prior to transmission oris sent on a second channel of the telemetry device. An electric powersource such as a lithium battery provides sufficient energy to power allthe component devices for a time period of at least 72 hours, themaximum transit time for the gastrointestinal tract. (The averagetransit time is 48 hours, with a range of 24 to 72 hours.)

[0021] The pose detector is not absolutely necessary for the successfuluse of this device. A trained physician will likely be able to infer theapproximate location of a given image from its appearance and the timeit is recorded (since the range of transit times through the parts ofthe tract are well documented).

[0022] In another form, the capsule includes a reception capability,such as a radio-frequency receiver, and an internal microprocessor thatallows instructions to be relayed from the physician to the capsule.Miniature motors allow the imaging system to be reoriented, or providesome form of “controlled mobility,” which could include a remotecontrol, joystick, mouse control or other computer-directed orvoice-directed control or other control. An expandable bladder attachedto the capsule can be expanded to stabilize the capsule or slow itsmotion through the tract. The system may also include on-board signalprocessing circuitry to automatically stabilize the image.Alternatively, a micro-machined mechanical stabilization platform can bebuilt into the imaging system. The imaging system may also include ameans such as a prism or fiber-optic device, to direct multiple imagesonto the imaging device.

[0023] In an alternate embodiment, a capsule would comprise an anteriormembrane with a port for an ultrasound sensor, a transmitter, a posebeacon, a power source, and a posterior membrane. The capsule would notinclude an imaging device or lens.

[0024] The anterior membrane is made of a non-allergenic, nondigestible,impervious material. The port is curved to match the curvature of anoutside surface of the anterior membrane. The posterior membrane is alsomade of a non-allergenic nondigestible impervious material, and mayinclude an integrated antenna for the transmitter.

[0025] Other forms of the capsule have the capacity for specializedtools including biopsy forceps and snares (with cold and hot snares withcoagulation and cutting current) for purposes like polypectomy andbaskets for retrieval and rat tooth forceps for retrieval and for otherminiature specialized devices. The operation of these devices iscontrolled in a similar fashion to the position of the capsule. Localmucosal resection can be performed in one embodiment with a combinationof hot snare cautery and suction. Furthermore, another form hastreatment tools using, for example, heat and electro cautery current,BICAP current, argon plasma coagulation and laser current. All thesecurrents can be continuous or time pulsed in cutting or coagulationmodes. Each of these embodiments mentioned above can be designed withthe imaging apparatus or without the imaging apparatus.

[0026] These tools can be connected to an elevator device within thecapsule allowing an extra range of movement of 180° for the tools.

[0027] One aspect of the present invention is the provision of a methodfor imaging a gastrointestinal tract that uses an ingestible device thatallows a patient to use the device while still performing normalactivities of daily living.

[0028] Another aspect of the present invention is that it wouldeliminate the need for highly trained personnel for its operation.

[0029] Yet another aspect of the present invention is that it iseconomically affordable and less expensive than existing methods ofimaging gastrointestinal tracts.

[0030] Still another aspect of the present invention is that it iseasier to implement and allows patients to be examined more frequentlythan existing methods of imaging gastrointestinal tracks.

[0031] Still other functions and benefits of an embodiment of theinvention include the ability to provide ultrasound imaging with aminiature ultrasound sensor and to image and treat problems with thepancreatic and biliary ducts and gastrointestinal system and the rest ofthe human body. In another embodiment, with a special dye injection portfor various dyes imaging of, for example, the biliary and pancreaticducts and the rest of the human body can be done. Treatment apparatusports allow for cutting and coagulation currents to be deliveredlocally.

[0032] Furthermore, a focal laser treatment, argon plasma coagulatortreatment, lithotripsy treatment with ultrasound current can be used inthe biliary and pancreatic ducts, gastrointestinal system and rest ofhuman body in other forms of the invention. In addition, tools includingminiature baskets, miniature snares, miniature needles with epinephrine(for example) and other treatments, miniature forceps, miniaturecytology brushes can be included in a form of the capsule for diagnosisand treatment in the biliary and pancreatic trees, pancreas, liver, andgastrointestinal system, and human body. Also, a thin wire, catheter,miniature plastic or metal stint can be deployed in the biliary andpancreatic ducts in other forms of the capsule. Finally, the capsule hassuction capabilities to remove unwanted debris and can sprinkle waterand n-acetyl cysteine locally over the lens or capsule to removeresidual debris from the gastrointestinal system to improve or enhancevisualization, diagnostic, therapeutic or other functions of thecapsule.

[0033] Still other benefits and advantages of the present invention willbecome apparent to those skilled in the art upon a reading andunderstanding of the following detailed specification.

BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The invention may take form in certain parts and arrangements ofparts, embodiments of which will be described in detail in thisspecification and illustrated in the accompanying drawings which form apart hereof and wherein:

[0035]FIG. 1 is a diagram showing the main components and signal flowfor the imaging system;

[0036]FIG. 2 is an exploded view of the capsule in accordance with thefirst embodiment of the present invention;

[0037]FIG. 3A is a perspective view of the capsule with an internal lensand a transparent window in the membrane in accordance with the firstembodiment of the present invention;

[0038]FIG. 3B is a sectional view of the capsule of FIG. 3A;

[0039]FIG. 4A is a perspective view of the capsule with an external lensin accordance with a second embodiment of the present invention;

[0040]FIG. 4B is a sectional view of the capsule with an external lensof FIG. 4A;

[0041]FIG. 5A is a perspective view of a capsule with an internal lensand a flat transparent window in the membrane in accordance with a thirdembodiment of the present invention;

[0042]FIG. 5B is a sectional view of the capsule of FIG. 5A;

[0043]FIG. 6 is a perspective view of a capsule with wheels inaccordance with a fourth embodiment of the present invention;

[0044]FIG. 7 is a perspective view of a capsule with fins in accordancewith a fifth embodiment of the present invention;

[0045]FIG. 8 is a perspective view of a capsule with prongs on aposterior membrane of the capsule in accordance with a sixth embodimentof the present invention;

[0046]FIG. 9 is a perspective view of a capsule with a port and atreatment tool in accordance with a seventh embodiment of the presentinvention;

[0047]FIG. 10 is a perspective view of a capsule with a treatment toolsuch as extendable biopsy forceps or extendable basket, retractablebasket, retractable rat tooth forceps, retractable cytelogy brush,retractable snares or other miniature devices for diagnosis and therapyin the human body in accordance with an eighth embodiment of the presentinvention;

[0048]FIG. 11 is a perspective view of a capsule with a treatment toolsuch as a retractable needle or retractable catheter for injection orretrieval in accordance with a ninth embodiment of the presentinvention;

[0049]FIG. 12 is a perspective view of a capsule with a suction port andsuction tube in accordance with a tenth embodiment of the presentinvention;

[0050]FIG. 13 is a perspective view of a capsule with a rotating lensand wiper in accordance with an eleventh embodiment of the presentinvention;

[0051]FIG. 14A is a perspective view of a capsule with an ultrasoundsensor port in accordance with a twelfth embodiment of the presentinvention; and

[0052]FIG. 14B is an exploded, perspective view of the capsule of FIG.14A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] Referring to the drawings, wherein the showings are for purposesof illustrating preferred embodiments of this invention only, and notfor purposes of limiting same, FIG. 1 shows a block diagram for thedevice. An illuminator 10 inside the capsule 12 projects light into thegastrointestinal tract. Images enter the capsule through a lens 14,impinging on an imaging array 16, the signal from which is thentransmitted by a transceiver 18 to a transceiver 20 outside of thecapsule. A power source 22 inside the capsule provides power to theimaging array 16, transceiver 18, and illuminator 10. The data from thetransceiver 18 is then relayed to a recording and display device 24.Simultaneously, a pose detection system 26 tracks a beacon 28 locatedinside the capsule and relays tracking information to the recording anddisplay system 24, which forms a display 30.

[0054] There are several external components to the external station 32.The basic system only requires the transceiver 20 to capture the imageinformation. A more complex design would include a transmitter in theexternal station and a receiver in the capsule, enabling the externalcontroller to transmit instructions to the capsule itself. The posedetection system 26 is a powered device that produces an RF signal or EMfield that allows the capsule's beacon to be tracked. The device can bestrapped to the patient's body. The pose data can be read by therecording and display device 24 and correlated with the image data. Therecording and display device 24 may be used to record and integrate theimage and pose data and data from other sources such as a CAT scan orMRI, and produce a display 30 for the physician.

[0055] Referring to FIG. 2 in accordance with the first preferredembodiment of the present invention, an imaging device A includes acapsule 40 including an anterior membrane 42 through which images areviewed, a lens 44 positioned within the membrane, an illumination device46 (comprising a light source and projection device) positioned adjacentto the lens, an imaging array 48, transmitter 50, a pose beacon 52, apower source 54, and a posterior membrane 60.

[0056] The anterior capsule membrane 42 is made of a non-allergenic,nondigestible, impervious material with at least one transparent windowor opening 62 for the lens 44. The window 62 is curved to match thecurvature of an outside surface of the anterior membrane 42. Theposterior membrane 60 is also made of a non-allergenic nondigestibleimpervious material, and may include an integrated antenna (not shown)for the transmitter.

[0057]FIGS. 3A and 3B show the capsule 40 in the assembledconfiguration. The transparent window 62 is made of a material to whichmucous and other biological materials will not adhere. An additionaladvantage of an internal lens design is that the lens can be mounted atan optimal distance to maintain focus.

[0058] The lens 44 may be mounted behind the transparent window 62 inthe capsule, or it may be mounted in an opening in the capsule so thatits front surface is exposed to the outside. The lens 44 may be aplastic or glass lens, a prism or a fiber optic bundle. One advantage ofa fiber optic bundle is that its front end can be designed to imageseveral views of the external environment, thus producing a compositeimage on the array plane. The focal length of the imaging system must besmall enough to achieve infinite focus at approximately 1 mm.

[0059] The simplest and most cost effective imaging array 48 is a CCD(charge-coupled device) array. It may be necessary to provide shieldingfor the CCD array to prevent RF interference from the transmitter. Aslightly oversized CCD array plus digital signal processor (DSP)circuitry can be included to allow real-time stabilization of the image,by time-correlating a series of images from the oversized array toilluminate image blur and shake electronically. New micromachiningtechnologies may be included in the array itself to provide imagestabilization. These devices would essentially incorporate a passive oractive damping system into the CCD chip itself. To maximize space foradditional circuitry such as a DSP for on-board image processing, signalmultiplexing and signal encoding can be constructed on flexible circuitboard that can wrap circumferentially around the inside of the capsule.

[0060] The type of illuminating device or light source 46 depends to acertain extent on the choice of imaging array. The use of a low-luximaging array obviates the need for a high-power light source. Thesource should approximate a white light source so that a color image canbe obtained. Methods for producing a white light source at very lowpower include 3-diode light source, inorganic LEDs, and full-colororganic electroluminescent sources. FIG. 2 shows a light source 46 whichis toroidally shaped and backed by a ring-semi-parabolic mirror,concentric with the window 62 and lens 44.

[0061] The pose beacon 52 provides a useful auxiliary piece ofinformation, the real-time position of the capsule relative to thepatient's body. This information will eliminate the discomfort of atether or the guesswork necessary in pinpointing the location ofabnormality by simple visual examination of the video or bytime-tracking the video. There currently exist several proven methods todetermine the six degree-of-freedom pose of a remote object, most oftenused in robotics to track mobile robots or to digitize human movements,for example, in hand-tracking and head-tracking controllers. Thesedevices use a RF or EM beacon that reflects signals from an externallyfixed transmitter, somewhat like a miniature radar system. Distances aretypically limited to a few meters cubic, which fall well within thespecifications for this device. The beacons are passive devices and willnot draw power from the onboard battery. External stations that can bestrapped or belted to the patient provide the signal sources. Given therecorded time-spacing tracking information, there are numerous ways todevelop a correspondence between the video images and the patient'sinternal structures. For example, a computer can overlay thetime-parametrized space-path of the capsule on an image based on CATscan or MRI of the patient, or over a computer-generated model based onthe patient's body size and shape. The video can then be synchronizedwith the capsule's motion on the computer screen.

[0062] The capsule requires a transmitter 50 rather than a transceiver.The simplest approach is to use a miniature amplitude modulation (AM)video transmitter in the 400 MHz-1.5 GHz region. Other standardtransmission methods include frequency modulation (FM), pulse-codemodulation (PCM), and frequency shift keying (FSK). For more complexarrangements, an on-board receiver will allow the base station tocommunicate with the capsule.

[0063] The power source 54, is a device of relatively high energydensity, capable of 10's of mA in the 0.5-9V range (these numbers arefor the current commercially available CCD and RF devices). The powersource 54 must fit within approximately ½ the volume of the capsule,approximately ⅓ cc, and must run the device for 72 hours at the bodytemperature (approximately 37° C.). Additionally, the nature of theimager will determine the amount of light necessary to provide thedesired image quality.

[0064] Off-the-shelf ⅓″ CCD board-cameras have power requirements in therange of 50-200 mA at 9VDC. However, a portion of this requirement isfor the line driver, which enables the output signal to be sent on along coaxial cable (e.g., 60′ plus). Since a line driver is not arequirement for this device, we can expect a much lower currentrequirement. Off-the-shelf video transmitters require approximately 50mA current at 9V. These devices, however, transmit signals at a designdistance of 100-500′.

[0065] The power source or battery 54 may also be designed to act as theballast to orient the capsule in the stomach. In other words, thebattery will be situated to the posterior of the capsule.

[0066] There are several lithium battery types currently used inimplantable biomedical applications. One type is lithium iodine. Theseare currently used in implantable cardiac pacemakers; microamp rangeover long periods, a 4 mm thick 10 mm radius disc has an energy volumeof 400 mA-hrs. Lithium Silver Vanadium Oxide batteries are used in bothhigh amperage applications (e.g., defibrillator) and medium amperageapplications (e.g., neurostimulators) and have a current of 50 mAcontinuous. Lithium Carbon Monofluoride batteries are used in mediumamperage applications such as neurostimulators and drug infusion pumps.

[0067] The battery 54 will include some form of integrated on-off switchfor the capsule, activated, for example, by twisting the posteriorcapsule with respect to the anterior capsule, or similar method thatwill not be accidentally actuated by peristalsis of the gut.

[0068] Referring now to FIGS. 4A and 4B, an imaging device B includes acapsule 70 with an external lens 72 in accordance with a secondpreferred embodiment of the present invention is shown. The frontsurface of the lens is exposed to the external environment. The lens 72is positioned on an outside surface of an anterior membrane 74 of thecapsule. This embodiment does not have a window. As discussed above, thecapsule further includes an illumination device 76, an imaging array(not shown), a transmitter 78, a pose beacon 80, a power source 82, anda posterior membrane 84. In case the desired lens material is not idealfor limiting fluid adherence, such that fluids may build up on itssurface and reduce image quality, a transparent window may be used.

[0069] Referring now to FIGS. 5A and 5B, an imaging device C includes acapsule 100 in accordance with a third preferred embodiment of thepresent invention is shown. The capsule 100 has an internal lens 102 anda flat transparent window 110 in the membrane.

[0070] The capsule further includes an illumination device 114, animaging array (not shown), a transmitter 116, a pose beacon 118, a powersource 120, and a posterior membrane 122.

[0071] Referring now to FIG. 6, wheels 140 may be added to the capsule150 in accordance with a fourth embodiment of the present invention. Thecapsule may be one of the three embodiments previously described. Thewheels would be powered by a remote control device (not shown). Thewheels 140 would have spokes 142 which would provide friction and enablethe wheels to move along surfaces. The capsule with wheels would be usedprimarily for situations where the stomach is virtually dry, not fluidfilled; such as a result of the patient fasting. Two sets of four wheels140 equally spaced may be placed around the circumference of thecapsule. Also, the capsule with wheels may be used in addition to asecond capsule. The capsule with wheels may provide a therapeuticfunction instead of a diagnostic function. That is, the capsule maysupply medicine or perform another therapeutic function to the areabeing investigated by the second capsule. One capsule would not be ableto detect the area being investigated through a video system as well asprovide medicine or other therapeutic relief.

[0072] In the situation where the stomach is at least partiallyfluid-filled, fins 160 in lieu of wheels may be placed on the exteriorsurface of capsule 170 as illustrated in a fifth embodiment in FIG. 7.The fins 160 would aid the capsule in moving throughout the stomach.

[0073] In a sixth embodiment, referring to FIG. 8, prongs 180 wouldextend from posterior end 182 of capsule 184. The prongs 180 can beretractable and would serve as a base for the capsule to effectivelyanchor or stabilize the capsule. A laser or biopsy forceps (not shown)could extend from the anterior portion 186 of the capsule.

[0074] In seventh embodiment, referring to FIG. 9, a port 200 isprovided in capsule 201 with an opening for a treatment tool 202, suchas a laser or ultrasound sensor. Alternatively, the treatment tool 202can be an argon plasma coagulator, BICAP or a dye injection device or aheat cautery.

[0075] Treatment tool 202 can include heat and electro cautery current,BICAP current, argon plasm coagulation or laser current. All thesecurrents can be continuous or time pulsed in cutting or coagulationmodes.

[0076] Ultrasound scanning or ultrasonography is a technique to imagehuman tissue. By definition, ultrasound is a sound wave having afrequency greater than 20 khz. The sound waves used in ultrasonographyare produced form a device called a transducer. Arrays of ultrasonicwaves scan tissue and are reflected back to the transducer.

[0077] Still other functions and benefits of an embodiment of theinvention include the ability to provide ultrasound imaging with aminiature ultrasound sensor and to image and treat problems with thepancreatic and biliary ducts and gastrointestinal system and the rest ofthe human body. In another embodiment, with a special dye injection portfor various dyes imaging of, for example, the biliary and pancreaticducts and the rest of the human body can be done. Treatment apparatusports allow for cutting and coagulation currents to be deliveredlocally.

[0078] Furthermore, treatment tool 202 can include a focal lasertreatment, argon plasma coagulator treatment, or lithotripsy treatmentwith ultrasound current which can be used in the biliary and pancreaticducts, gastrointestinal system and rest of human body in other forms ofthe invention.

[0079] In an eighth embodiment (FIG. 10), a treatment tool 300 is addedto a port in the front portion of the capsule 302. A retractable lever304 protrudes from the capsule exposing the tool 300. Upon completion ofthe treatment operation, the tool may be retracted within the capsule.

[0080] The specialized tool 300 can include biopsy forceps orretractable snares (with cold and hot snares with coagulation andcutting current) for purposes like polypectomy. Alternatively, tool 300can include an extendable basket, retractable basket, retractable rattooth forceps, retractable cytology brush, which can be used fordiagnosis and therapy in the human body. Miniature snares, miniatureneedles with epinephrine (for example) and other treatments, miniatureforceps, miniature cytology brushes can be included in a form of thecapsule for diagnosis and treatment in the biliary and pancreatic trees,pancreas, liver, and gastrointestinal system, and human body. Theoperation of these devices is controlled in a similar fashion to theposition of the capsule. Local mucosal resection can be performed in oneembodiment with a combination of hot snare cautery and suction. Each ofthese embodiments mentioned above can be designed with the imagingapparatus or without the imaging apparatus.

[0081] In a ninth embodiment (FIG. 11), a treatment tool 400 forinjection or retrieval (such as a needle or catheter) would be added tocapsule 402. The tool 400 would be retractable into the capsule. Aneedle would be a sclerotherapy needle to sclerose a dilated vein.Alternatively, the needle could provide epinephrine to a bleeding vesselto stop bleeding. Also, tool 400 can include a thin wire, catheter, or aminiature plastic or metal stent can be deployed in the biliary andpancreatic ducts in other forms of the capsule.

[0082] In a tenth embodiment (FIG. 12), a suction port 500 is providedin capsule 502. The suction port 500 would pass through the capsule fromanterior portion 504 to posterior portion 506 of the capsule. Fluid isthen suctioned through a suction tube 508 through the suction port ofthe capsule. The capsule would have suction capabilities to removeunwanted debris and can sprinkle water and n-acetyl cysteine locallyover the lens or capsule to remove residual debris from thegastrointestinal system to improve or enhance visualization, diagnostic,therapeutic or other functions of the capsule.

[0083] In an eleventh embodiment referring to FIG. 13, a rotating lens600 for capsule 602 is provided which rotates on an axis (not shown).The lens contains a small amount of liquid (such as alcohol withn-acetylcysteine or water) to clean the surface of the lens with arotating wiper 610. The wiper rotates on the same axis as the lens.

[0084] Referring to FIGS. 14A and 14B, in a twelfth embodiment, acapsule 700 would comprise an anterior membrane 702 with a port 704 foran ultrasound sensor 706, a transmitter 708, a pose beacon 710, a powersource 712, and a posterior membrane 714. The capsule would not includean imaging device or lens.

[0085] The anterior membrane. 702 is made of a non-allergenic,nondigestible, impervious material. The port 704 is curved to match thecurvature of an outside surface of the anterior membrane. The posteriormembrane 714 is also made of a non-allergenic nondigestible imperviousmaterial, and may include an integrated antenna (not shown) for thetransmitter. Embodiments illustrated in FIGS. 6-13 and discussed abovecan also be incorporated into capsule 700.

[0086] Each of the treatment tools 202, 300 and 400 can be connected toan elevator device (not shown) which is used to elevate or lift thetreated tools through different angles with a remote control deviceadding an additional 180° of range of movement.

[0087] Each capsule can include a reception capability, such as aradio-frequency receiver, and an internal microprocessor that allowsinstructions to be relayed from the physician to the capsule. Miniaturemotors allow the imaging system to be reoriented, or provide some formof “controlled mobility,” which could include a remote control,joystick, mouse control or other computer-directed or voice-directedcontrol or other control (not shown). An expandable bladder attached tothe capsule can be expanded to stabilize the capsule or slow its motionthrough the tract. The system may also include on-board signalprocessing circuitry to automatically stabilize the image.Alternatively, a micro-machined mechanical stabilization platform can bebuilt into the imaging system. The imaging system may also include ameans such as a prism or fiber-optic device, to direct multiple imagesonto the imaging device.

[0088] The invention has been described with reference to a preferredinitial embodiment. Obviously, alterations and modifications will occurto others upon a reading and understanding of this specification. It isintended to include all such modifications and alternations insofar asthey come within the scope of the appended claims or the equivalentsthereof.

Having thus described the preferred embodiment, the invention is nowclaimed:
 1. An imaging device comprising: a membrane defining aninternal cavity and being provided with a window; a lens disposed inrelation to said window; a light source disposed in relation to saidlens for providing illumination to outside of said membrane through saidwindow; an imaging array disposed in relation to said lens, whereinimages from said lens impinge on said imaging array; and a transmitterdisposed in relation to said imaging array for transmitting a signalfrom said imaging array to an associated transmitter outside of saidcapsule, said lens, light source and projection device, imaging array,and transmitter being enclosed within said internal cavity.
 2. Theimaging device of claim 1, further comprising a pose beacon, said beaconbeing tracked by an associated pose detection system outside of saidimaging device and tracking information is relayed to an associatedrecording and display system.
 3. The imaging device of claim 1, furthercomprising a power source which provides power to said imaging array,said transmitter and said light source.
 4. The imaging device of claim1, wherein said membrane is made of a non-allergenic, non-digestible,impervious material.
 5. The imaging device of claim 1, wherein said lensis made from plastic.
 6. The imaging device of claim 1, wherein saidlens is made from glass.
 7. The imaging device of claim 1, wherein saidlens is made from a fiber optic bundle.
 8. The imaging device of claim1, wherein said imaging array is a charged-couple device array.
 9. Theimaging device of claim 1, wherein said light source is a toroidallyshaped source with a ring-semi parabolic mirror which is concentric withsaid window.
 10. The imaging device of claim 1, wherein said transmitteris a miniature amplitude modulation video transmitter in the 400 MHz-1.5GHz region.
 11. The imaging device of claim 1, wherein said window ismade from a material to which mucous and other biological materials willnot adhere.
 12. The imaging device of claim 1 wherein said window has aflat surface.
 13. The imaging device of claim 1 wherein said window hasa curved surface.
 14. The imaging device of claim 1 further comprisingat least one pair of wheels extending from said membrane.
 15. Theimaging device of claim 1 further comprising at least one pair of finsextending from said membrane.
 16. The imaging device of claim 1 furthercomprising at least one pair of prongs extending from said membrane forstabilizing said device.
 17. The imaging device of claim 1 furthercomprising a port comprising an opening for a miniature laser device anda miniature laser device positioned within said opening.
 18. The imagingdevice of claim 1 further comprising a port comprising an opening for aminiature ultrasound sensor and a miniature ultrasound sensor positionedwithin said opening.
 19. The imaging device of claim 1 furthercomprising a port comprising an opening for a miniature argon plasmacoagulator and a miniature argon plasma coagulator positioned withinsaid opening.
 20. The imaging device of claim 1 further comprising aport comprising an opening for a miniature heat cautery and a miniatureheat cautery positioned within said opening.
 21. The imaging device ofclaim 1 further comprising a port comprising an opening for a miniaturebiopsy forceps and miniature biopsy forceps, said forceps beingretractable within said opening.
 22. The imaging device of claim 1further comprising a port comprising an opening for a miniature needleand a miniature needle, said needle being retractable within saidopening.
 23. The imaging device of claim 1 further comprising a suctionport and a suction tube, said tube passes through said suction port. 24.The imaging device of claim l wherein said lens is rotatable about anaxis.
 25. The imaging device of claim 24 further comprising a rotatablewiper mounted on said lens.
 26. The imaging device of claim 1 furthercomprising a port comprising an opening for a miniature snare, and aminiature snare positioned with said opening for coagulation and cuttingcautery.
 27. The imaging device of claim 1 further comprising a portcomprising an opening for a miniature BICAP, and a miniature BICAPpositioned within said opening.
 28. The imaging device of claim 1further comprising a port comprising an opening for a miniature cytologybrush, and a miniature cytology brush positioned within said opening.29. The imaging device of claim 1 further comprising a port comprisingan opening for a miniature catheter and a miniature catheter retractablewithin said opening for injecting imaging dye.
 30. The imaging device ofclaim 1 further comprising a port comprising an opening for a miniaturelithotripsy device, and a miniature lithotripsy device positioned withinsaid opening.
 31. The imaging device of claim 1 further comprising aport comprising an opening for a miniature rat tooth forceps, and aminiature rat tooth forceps located within said opening.
 32. The imagingdevice of claim 1 wherein movement of said device is controlled by aremote external source.
 33. The imaging device of claim 17 furthercomprising an elevation device connected to said miniature laser devicefor raising and lowering said miniature laser device, said elevationdevice being controlled by an external source.
 34. The imaging device ofclaim 18 further comprising an elevation device connected to saidminiature ultrasound sensor for raising and lowering said miniatureultrasound sensor, said elevation device being controlled by an externalsource.
 35. The imaging device of claim 19 further comprising anelevation device connected to said miniature argon plasma coagulator forraising and lowering said miniature argon plasma coagulator, saidelevation device being controlled by an external source.
 36. The imagingdevice of claim 20 further comprising an elevation device connected tosaid miniature heat cautery for raising and lowering said miniature heatcautery, said elevation device being controlled by an external source.37. The imaging device of claim 21 further comprising an elevationdevice connected to said miniature biopsy forceps for raising andlowering said miniature biopsy forceps, said elevation device beingcontrolled by an external source.
 38. The imaging device of claim 22further comprising an elevation device connected to said miniatureneedle for raising and lowering said miniature needle, said elevationdevice being controlled by an external source.
 39. The imaging device ofclaim 26 further comprising an elevation device connected to saidminiature snare for raising and lowering said miniature snare, saidelevation device being controlled by an external source.
 40. The imagingdevice of claim 27 further comprising an elevation device connected tosaid miniature BICAP for raising and lowering said miniature BICAP, saidelevation device being controlled by an external source.
 41. The imagingdevice of claim 28 further comprising an elevation device connected tosaid miniature cytology brush for raising and lowering said miniaturecytology brush, said elevation device being controlled by an externalsource.
 42. The imaging device of claim 29 further comprising anelevation device connected to said miniature catheter for raising andlowering said miniature catheter, said elevation device being controlledby an external source.
 43. The imaging device of claim 30 furthercomprising an elevation device connected to said miniature lithotripsydevice for raising and lowering said miniature lithotripsy device, saidelevation device being controlled by an external source.
 44. The imagingdevice of claim 31 further comprising an elevation device connected tosaid miniature rat tooth forceps for raising and lowering said miniaturerat tooth forceps, said elevation device being controlled by an externalsource.
 45. An imaging device comprising: an anterior membrane; aposterior membrane connected to said anterior membrane, said anteriormembrane and said posterior membrane define an internal cavity; a lensdisposed on an outside surface of said anterior membrane; a light sourceand projection device disposed in relation to said lens for providingillumination to outside of said anterior membrane; an imaging arraydisposed in relation to said lens, wherein images from said lens impingeon said imaging array; a transmitter disposed in relation to saidimaging array for transmitting a signal from said imaging array to anassociated transmitter outside of said capsule; a pose beacon positionedin relation to said transmitter; said light source and projectiondevice, imaging array, transmitter, and pose beacon are enclosed withinsaid internal cavity.
 46. The imaging device of claim 45, furthercomprising a power source which provides power to said imaging array,said transmitter and said light source and projection device.
 47. Theimaging device of claim 45, wherein said anterior membrane is made of anon-allergenic, non-digestible, impervious material.
 48. The imagingdevice of claim 45, wherein said posterior membrane is made of anon-allergenic, non-digestible, impervious material.
 49. The imagingdevice of claim 45 further comprising at least one pair of wheelsextending from one of said anterior membrane and said posteriormembrane.
 50. The imaging device of claim 45 further comprising at leastone pair of fins extending from one of said anterior membrane and saidposterior membrane.
 51. The imaging device of claim 45 furthercomprising at least one pair of prongs extending from said posteriormembrane for stabilizing said device.
 52. The imaging device of claim 45further comprising a port comprising an opening for a miniature laserdevice and a miniature laser device positioned within said opening. 53.The imaging device of claim 45 further comprising a port comprising anopening for a miniature ultrasound sensor and a miniature ultrasoundsensor positioned within said opening.
 54. The imaging device of claim45 further comprising a port comprising an opening for a miniature argonplasma coagulator and a miniature argon plasma coagulator positionedwithin said opening.
 55. The imaging device of claim 45 furthercomprising a port comprising an opening for a miniature heat cautery anda miniature heat cautery positioned within said opening.
 56. The imagingdevice of claim 45 further comprising a port comprising an opening for aminiature biopsy forceps and a miniature biopsy forceps, said forcepsbeing retractable within said opening.
 57. The imaging device of claim45 further comprising a port comprising an opening for a miniatureneedle and a miniature needle, said needle being retractable within saidopening.
 58. The imaging device of claim 45 further comprising a suctionport and a suction tube, said tube passes through said suction port. 59.The imaging device of claim 45 wherein said lens is rotatable about anaxis.
 60. The imaging device of claim 59 further comprising a rotatablewiper mounted on said lens.
 61. The imaging device of claim 45 furthercomprising a port comprising an opening for a miniature snare, and aminiature snare positioned with said opening for coagulation and cuttingcautery.
 62. The imaging device of claim 45 further comprising a portcomprising an opening for a miniature BICAP, and a miniature BICAPpositioned within said opening.
 63. The imaging device of claim 45further comprising a port comprising an opening for a miniature cytologybrush, and a miniature cytology brush positioned within said opening.64. The imaging device of claim 45 further comprising a port comprisingan opening for a miniature catheter and a miniature catheter retractablewithin said opening for injecting imaging dye.
 65. The imaging device ofclaim 45 further comprising a port comprising an opening for a miniaturelithotripsy device, and a miniature lithotripsy device positioned withinsaid opening.
 66. The imaging device of claim 45 further comprising aport comprising an opening for a miniature rat tooth forceps, and aminiature rat tooth forceps located within said opening.
 67. The imagingdevice of claim 52 further comprising an elevation device connected tosaid miniature laser device for raising and lowering said miniaturelaser device, said elevation device being controlled by an externalsource.
 68. The imaging device of claim 53 further comprising anelevation device connected to said miniature ultrasound sensor forraising and lowering said miniature ultrasound sensor, said elevationdevice being controlled by an external source.
 69. The imaging device ofclaim 54 further comprising an elevation device connected to saidminiature argon plasma coagulator for raising and lowering saidminiature argon plasma coagulator, said elevation device beingcontrolled by an external source.
 70. The imaging device of claim 55further comprising an elevation device connected to said miniature heatcautery for raising and lowering said miniature heat cautery, saidelevation device being controlled by an external source.
 71. The imagingdevice of claim 56 further comprising an elevation device connected tosaid miniature biopsy forceps for raising and lowering said miniaturebiopsy forceps, said elevation device being controlled by an externalsource.
 72. The imaging device of claim 57 further comprising anelevation device connected to said miniature needle for raising andlowering said miniature needle, said elevation device being controlledby an external source.
 73. The imaging device of claim 61 furthercomprising an elevation device connected to said miniature snare forraising and lowering said miniature snare, said elevation device beingcontrolled by an external source.
 74. The imaging device of claim 62further comprising an elevation device connected to said miniature BICAPfor raising and lowering said miniature BICAP, said elevation devicebeing controlled by an external source.
 75. The imaging device of claim63 further comprising an elevation device connected to said miniaturecytology brush for raising and lowering said miniature cytology brush,said elevation device being controlled by an external source.
 76. Theimaging device of claim 64 further comprising an elevation deviceconnected to said miniature catheter for raising and lowering saidminiature catheter, said elevation device being controlled by anexternal source.
 77. The imaging device of claim 65 further comprisingan elevation device connected to said miniature lithotripsy device forraising and lowering said miniature lithotripsy device, said elevationdevice being controlled by an external source.
 78. The imaging device ofclaim 66 further comprising an elevation device connected to saidminiature rat tooth forceps for raising and lowering said miniature rattooth forceps, said elevation device being controlled by an externalsource.
 79. An imaging system comprising: a capsule, said capsulecomprising: an anterior membrane, said membrane comprises a window; aposterior membrane connected to said anterior membrane, said anteriormembrane and said posterior membrane define an internal cavity; a lensdisposed in relation to said window; a light source and projectiondevice disposed in relation to said lens for providing illumination tooutside of said anterior membrane; an imaging array disposed in relationto said lens, wherein images from said lens impinge on said imagingarray; a first transmitter disposed in relation to said imaging array; apose beacon positioned in relation to said transmitter; said lens, lightsource and projection device, imaging array, transmitter, and posebeacon are enclosed within said internal cavity; a second transmitterlocated outside of said capsule, said first transmitter transmits asignal from said imaging array to said second transmitter; a posedetection system outside of said capsule, said pose detection systemtracks said pose beacon; and a recording and display device, said posedetection system relays tracking information to said recording anddisplay device.
 80. The imaging system of claim 79, wherein saidanterior membrane is made of a non-allergenic, non-digestible,impervious material.
 81. The imaging system of claim 79, wherein saidposterior membrane is made of a non-allergenic, non-digestible,impervious material.
 82. The imaging system of claim 79, wherein saidimaging array is a charged-couple device array.
 83. The imaging systemof claim 79, wherein said light source is a toroidally shaped sourcewith a ring-semi parabolic mirror which is concentric with said window.84. The imaging system of claim 79, wherein said first transmitter is aminiature amplitude modulation video transmitter in the 400 MHz-1.5 GHzregion.
 85. The imaging system of claim 79, wherein said window is madefrom a material to which mucous and other biological materials will notadhere.
 86. The imaging system of claim 79 wherein said window has aflat surface.
 87. The imaging system of claim 79 wherein said window hasa curved surface.
 88. The imaging system of claim 79 further comprisingat least one pair of wheels extending from one of said anterior membraneand said posterior membrane.
 89. The imaging system of claim 79 furthercomprising at least one pair of fins extending from one of said anteriormembrane and said posterior membrane.
 90. The imaging system of claim 79further comprising at least one pair of prongs extending from saidposterior membrane for stabilizing said capsule.
 91. The imaging systemof claim 79 further comprising a port comprising an opening for aminiature laser device and a miniature laser device.
 92. The imagingsystem of claim 79 further comprising a port comprising an opening for aminiature ultrasound sensor and a miniature ultrasound sensor.
 93. Theimaging system of claim 79 further comprising a port comprising anopening for a miniature argon plasma coagulator and a miniature argonplasma coagulator.
 94. The imaging system of claim 79 further comprisinga port comprising an opening for a miniature heat cautery and aminiature heat cautery.
 95. The imaging system of claim 79 furthercomprising a port comprising an opening for miniature biopsy forceps andminiature biopsy forceps, said forceps being retractable within saidopening.
 96. The imaging system of claim 79 further comprising a portcomprising an opening for a miniature needle and a miniature needle,said needle being retractable within said opening.
 97. The imagingsystem of claim 79 further comprising a suction port and a suction tube,said tube passes through said suction port.
 98. The imaging system ofclaim 79 wherein said lens is rotatable about an axis.
 99. The imagingsystem of claim 98 further comprising a rotatable wiper mounted on saidlens.
 100. The imaging device of claim 79 further comprising a portcomprising an opening for a miniature snare, and a miniature snarepositioned with said opening for coagulation and cutting cautery. 101.The imaging device of claim 79 further comprising a port comprising anopening for a miniature BICAP, and a miniature BICAP positioned withinsaid opening.
 102. The imaging device of claim 79 further comprising aport comprising an opening for a miniature cytology brush, and aminiature cytology brush positioned within said opening.
 103. Theimaging device of claim 79 further comprising a port comprising anopening for a miniature catheter and a miniature catheter retractablewithin said opening for injecting imaging dye.
 104. The imaging deviceof claim 79 further comprising a port comprising an opening for aminiature lithotripsy device, and a miniature lithotripsy devicepositioned within said opening.
 105. The imaging device of claim 79further comprising a port comprising an opening for a miniature rattooth forceps, and a miniature rat tooth forceps located within saidopening.
 106. The imaging device of claim 91 further comprising anelevation device connected to said miniature laser device for raisingand lowering said miniature laser device, said elevation device beingcontrolled by an external source.
 107. The imaging device of claim 92further comprising an elevation device connected to said miniatureultrasound sensor for raising and lowering said miniature ultrasoundsensor, said elevation device being controlled by an external source.108. The imaging device of claim 93 further comprising an elevationdevice connected to said miniature argon plasma coagulator for raisingand lowering said miniature argon plasma coagulator, said elevationdevice being controlled by an external source.
 109. The imaging deviceof claim 94 further comprising an elevation device connected to saidminiature heat cautery for raising and lowering said miniature heatcautery, said elevation device being controlled by an external source.110. The imaging device of claim 95 further comprising an elevationdevice connected to said miniature biopsy forceps for raising andlowering said miniature biopsy forceps, said elevation device beingcontrolled by an external source.
 111. The imaging device of claim 96further comprising an elevation device connected to said miniatureneedle for raising and lowering said miniature needle, said elevationdevice being controlled by an external source.
 112. The imaging deviceof claim 100 further comprising an elevation device connected to saidminiature snare for raising and lowering said miniature snare, saidelevation device being controlled by an external source.
 113. Theimaging device of claim 101 further comprising an elevation deviceconnected to said miniature BICAP for raising and lowering saidminiature BICAP, said elevation device being controlled by an externalsource.
 114. The imaging device of claim 102 further comprising anelevation device connected to said miniature cytology brush for raisingand lowering said miniature cytology brush, said elevation device beingcontrolled by an external source.
 115. The imaging device of claim 103further comprising an elevation device connected to said miniaturecatheter for raising and lowering said miniature catheter, saidelevation device being controlled by an external source.
 116. Theimaging device of claim 104 further comprising an elevation deviceconnected to said miniature lithotripsy device for raising and loweringsaid miniature lithotripsy device, said elevation device beingcontrolled by an external source.
 117. The imaging device of claim 105further comprising an elevation device connected to said miniature rattooth forceps for raising and lowering said miniature rat tooth forceps,said elevation device being controlled by an external source.
 118. Acapsule comprising: an anterior membrane; a posterior membrane connectedto said anterior membrane, said anterior membrane and said posteriormembrane define an internal cavity; a port disposed on a surface of saidanterior membrane; an ultrasound sensor disposed within said port; and atransmitter disposed in relation to said port with said capsule fortransmitting a signal from said port to an associated transmitteroutside of said capsule.
 119. The capsule of claim 118, furthercomprising a pose beacon, said beacon being tracked by an associatedpose detection system outside of said capsule and tracking informationis relayed to an associated recording and display system.
 120. Thecapsule of claim 118, further comprising a power source which providespower to said port and said transmitter.
 121. The capsule of claim 118,wherein said anterior membrane and said posterior membrane are made of anon-allergenic, non-digestible, impervious material.
 122. The capsule ofclaim 118, wherein said transmitter is a miniature amplitude modulationvideo transmitter in the 400 MHz-1.5 GHz region.
 123. The capsule ofclaim 118, wherein said port is made from a material to which mucous andother biological materials will not adhere.
 124. The capsule of claim118 wherein said port has a curved surface.
 125. The capsule of claim118 further comprising at least one pair of wheels extending from one ofsaid anterior membrane and said posterior membrane.
 126. The capsule ofclaim 118 further comprising at least one pair of fins extending fromone of said anterior membrane and said posterior membrane.
 127. Thecapsule of claim 118 further comprising at least one pair of prongsextending from said posterior membrane for stabilizing said capsule.128. The imaging device of claim 118 further comprising a portcomprising an opening for a miniature laser device and a miniature laserdevice positioned within said opening.
 129. The imaging device of claim118 further comprising a port comprising an opening for a miniatureultrasound sensor and a miniature ultrasound sensor positioned withinsaid opening.
 130. The imaging device of claim 118 further comprising aport comprising an opening for a miniature argon plasma coagulator and aminiature argon plasma coagulator positioned within said opening. 131.The imaging device of claim 118 further comprising a port comprising anopening for a miniature heat cautery and a miniature heat cauterypositioned within said opening.
 132. The imaging device of claim 118further comprising a port comprising an opening for a miniature biopsyforceps and miniature biopsy forceps, said forceps being retractablewithin said opening.
 133. The imaging device of claim 118 furthercomprising a port comprising an opening for a miniature needle and aminiature needle, said needle being retractable within said opening.134. The imaging device of claim 118 further comprising a suction portand a suction tube, said tube passes through said suction port.
 135. Theimaging device of claim 118 wherein said lens is rotatable about anaxis.
 136. The imaging device of claim 135 further comprising arotatable wiper mounted on said lens.
 137. The imaging device of claim118 further comprising a port comprising an opening for a miniaturesnare, and a miniature snare positioned with said opening forcoagulation and cutting cautery.
 138. The imaging device of claim 118further comprising a port comprising an opening for a miniature BICAP,and a miniature BICAP positioned within said opening.
 139. The imagingdevice of claim 118 further comprising a port comprising an opening fora miniature cytology brush, and a miniature cytology brush positionedwithin said opening.
 140. The imaging device of claim 118 furthercomprising a port comprising an opening for a miniature catheter and aminiature catheter retractable within said opening for injecting imagingdye.
 141. The imaging device of claim 118 further comprising a portcomprising an opening for a miniature lithotripsy device, and aminiature lithotripsy device positioned within said opening.
 142. Theimaging device of claim 118 further comprising a port comprising anopening for a miniature rat tooth forceps, and a miniature rat toothforceps located within said opening.
 143. The imaging device of claim128 further comprising an elevation device connected to said miniaturelaser device for raising and lowering said miniature laser device, saidelevation device being controlled by an external source.
 144. Theimaging device of claim 129 further comprising an elevation deviceconnected to said miniature ultrasound sensor for raising and loweringsaid miniature ultrasound sensor, said elevation device being controlledby an external source.
 145. The imaging device of claim 130 furthercomprising an elevation device connected to said miniature argon plasmacoagulator for raising and lowering said miniature argon plasmacoagulator, said elevation device being controlled by an externalsource.
 146. The imaging device of claim 131 further comprising anelevation device connected to said miniature heat cautery for raisingand lowering said miniature heat cautery, said elevation device beingcontrolled by an external source.
 147. The imaging device of claim 132further comprising an elevation device connected to said miniaturebiopsy forceps for raising and lowering said miniature biopsy forceps,said elevation device being controlled by an external source.
 148. Theimaging device of claim 133 further comprising an elevation deviceconnected to said miniature needle for raising and lowering saidminiature needle, said elevation device being controlled by an externalsource.
 149. The imaging device of claim 137 further comprising anelevation device connected to said miniature snare for raising andlowering said miniature snare, said elevation device being controlled byan external source.
 150. The imaging device of claim 138 furthercomprising an elevation device connected to said miniature BICAP forraising and lowering said miniature BICAP, said elevation device beingcontrolled by an external source.
 151. The imaging device of claim 139further comprising an elevation device connected to said miniaturecytology brush for raising and lowering said miniature cytology brush,said elevation device being controlled by an external source.
 152. Theimaging device of claim 140 further comprising an elevation deviceconnected to said miniature catheter for raising and lowering saidminiature catheter, said elevation device being controlled by anexternal source.
 153. The imaging device of claim 141 further comprisingan elevation device connected to said miniature lithotripsy device forraising and lowering said miniature lithotripsy device, said elevationdevice being controlled by an external source.
 154. The imaging deviceof claim 142 further comprising an elevation device connected to saidminiature rat tooth forceps for raising and lowering said miniature rattooth forceps, said elevation device being controlled by an externalsource.
 155. A method for imaging a gastrointestinal tract, comprisingthe steps of: providing a capsule for ingestion, illuminating thegastrointestinal tract via a light source within the capsule, providinga lens for entering images into the capsule, impinging the images ontoan imaging array, and transmitting a signal from the imaging array to atransmitter outside of the capsule.
 156. A method of claim 155, furthercomprising the step of: relaying data from the transmitter outside ofthe capsule to a recording and display system.
 157. The method of claim155, further comprising the step of: tracking a beacon located withinthe capsule and relaying the information to the recording and displaysystem.